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AI may allow safer breast MRIs with lower contrast doses

NCT ID NCT04340180

Diagnosis Sponsor: University of Alabama at Birmingham Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 2 times

Summary

This study tested whether artificial intelligence (AI) can help doctors accurately identify breast tumors on MRIs that use a lower dose of gadolinium contrast dye. Reducing the dose may lower the amount of gadolinium deposited in the brain. The study included 20 women—half with breast cancer and half with benign findings—and compared low-dose images to standard-dose images using AI assistance.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

20 people

The number who actually took part.

Started

Jul 2021

Finished

Jan 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria for Breast Cancer Patients: * Female patient between ≥ 18 years old and ≤ 99 years old * Patients with newly diagnosed primary breast cancer * Patient able and willing to participate in the trial Inclusion criteria for Non-malignant indications: * Female patients between ≥ 18 years old and ≤ 99 years old * Be referred for MRI for non-malignant indications (screening or BIRADS 3) * Patients have had prior exam with known enhancing mass, nonmass enhancement, or focus/foci. Exclusion Criteria: * Non-female patients * Patients \< 18 years old * Women who are lactating or pregnant * Patients with recurrent breast cancer * Patients who have already received neoadjuvant chemotherapy * Unable to lie still on the imaging table for one (1) hour * Patients that are unable to undergo MRI evaluation for reasons specific to MRI

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Conditions

The condition(s) this trial relates to.

breast benign neoplasm breast cancer breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast benign tumor Breast malignant tumor

Contacts and locations

Locations

  • The Kirklin Clinic

    Birmingham, Alabama, 35249, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.